Posts Tagged ‘FDA’

The Public Health Advocacy Institute at Northeastern University School of Law and its President, Dick Daynard have long sought to make an impact on public health and policy by thinking outside the box. In an op-ed piece published in today’s New York Times, Daynard looks at an endgame for cigarette-caused addiction, disease and death in the U.S. and focuses in on two complementary but independent regulatory strategies.

The first strategy, available to the FDA under its authority granted in 2009 by Congress through the Family Smoking Prevention and Tobacco Control Act, is to reduce the nicotine content of cigarettes (and cigarette-like products) to non-addictive levels. Reducing nicotine yields of tobacco products (to anything above zero) is specifically mentioned in the law and, given strong evidence that it would benefit public health, there is nothing stopping the FDA from taking this bold step. While many smokers will quit if cigarettes do not deliver sufficient nicotine to maintain their addiction, others may chose to use tobacco products with higher levels of nicotine. But because cigarettes are, far and away, the most toxic product available for delivering nicotine, making them non-addictive is the only responsible thing to do. It will help existing smokers to quit or move to less dangerous sources of nicotine, stop smoking experimentation by youth from becoming a deadly addiction, and dramatically reduce non-smokers’ exposure to tobacco smoke. Public polling, while limited, consistently shows significant support, even by smokers, for reducing nicotine in cigarettes.

The second strategy relies on states and even communities regulating the sales of cigarettes under the principles of a proposal that has gained some traction outside of the U.S., called the Smokefree Millennial Generation. I feel it should be named in honor of the late Dr. C. Everett Koop who once challenged America of become a smokefree nation by 2000. The idea is that if a person’s birth year begins with the number “2,” that person shall not purchase cigarettes (or little cigars or other cigarette-like products). The legal authority for states and communities to enact such sales restrictions was clearly stated in the legislation that granted the FDA regulatory authority over tobacco (although communities could be preempted in some states). This proposal would gradually phase out smoking, beginning with the Millennials in 2018, wherever it was enacted. As more states adopted this policy, there would be fewer places willing to sell cigarettes to 18-year-olds who are unlikely to have the mobility to get a sufficient cross-border supply to initiate or maintain addiction.

While each of these strategies would face likely legal challenges that would delay but probably not overturn the regulatory policies in question, as well as public relations and implementation challenges, the time has finally come to put an end to smoking and smoking-caused disease by focusing narrowly on the highest impact policies that would dramatically reduce smoking rates in a decade. It is PHAI’s hope that today’s op-ed will generate a discussion and support among public health and tobacco control leaders so we can work together to truly achieve our shared goal of sharply reducing preventable death and disease. Eliminating smoking may seem way outside the box, but it is the best place to start.

Mark Gottlieb, executive director of the Public Health Advocacy Institute at Northeastern University School of Law in Boston states:

“Today’s ruling leaves the FDA in a very difficult position as it seeks to execute the intent of Congress which specifically called for large graphic warnings on cigarette packs. By this Court’s logic, the small Surgeon General textual warnings might also violate the cigarette companies’ rights to commercial free speech because there is inadequate scientific proof that those labels reduce smoking rates. Surely a product that addicts and kills nearly a half million Americans each year is one that demands warnings that garner serous attention by consumers. Todays’ decision is an improper imposition of the Court’s judgment in public health matters over that of the FDA’s evidence-based approach. Ultimately, an appeal to the U.S. Supreme Court, although risky, seems inevitable. “

U.S. Court of Appeals for DC Circuit deals painful blow to FDA, public health and consumers

Today the U.S. Court of Appeals for the D.C. Circuit, in a 2-1 ruling, affirmed the February 29, 2012 ruling of Judge Richard Leon that stopped the U.S. Food and Drug Administration (FDA) from implementing regulations to require large graphic warnings on cigarette packs and on all cigarette advertising. The Court ruled that requiring the five cigarette companies bringing the lawsuit to include the 9 graphic images selected by the FDA violated their First Amendment rights.

Questions about the how much the government can limit the speech of corporations and, in this case, how much the government can compel speech by corporations, evolved over time through decisions issued the U.S. Supreme Court. Different standards apply depending on the circumstances. At issue in this case is which standard is appropriate.

The District Court applied a standard known as strict scrutiny which is the most stringent standard. It is generally used when state action affects fundamental Constitutional right is threatened. Here, the Court of Appeals used the Central Hudson Intermediate Scrutiny Standard. This standard requires the government to show that: a) it has a important interest in the issue at hand; b) that the regulation directly advances that interest; and c) that the restriction on speech is no more extensive than required to achieve its purpose. The Court of Appeals found that the FDA failed to demonstrate adequately that the graphic warnings would achieve its interest in reducing smoking rates through scientific evidence. It also found that an alternative government interest in effectively communicating health information to consumers is too vague to qualify as a substantial government interest.

The alternative standard that could have applied is known as the Zauderer standard. This standard allows disclosures to be required so long as they are reasonably related to the government’s interest in preventing consumer deception. The Court of Appeals today relied on decisions that held that without such disclosures there is a serious risk that consumers will be misled. Then the Court notes that in the legislation that gave the FDA authority of cigarettes (the Family Smoking Prevention and Tobacco Control Act of 2009) several provisions were included to protect consumers from deception such as prohibiting cigarette makers from using descriptors such as “light” or “mild.” Because Congress included those provisions and said nothing about cigarette packaging or advertising being inherently deceptive, it ruled that the Zauderer standard did not apply. The majority opinion was written by Judge Janice Rogers Brown who was joined by Senior Circuit Judge A. Raymond Randolph.

In a vigorous dissent written by Judge Judith W. Rogers, it is argued that the Court should have applied the Zauderer standard because the warnings are provided to address misleading commercial speech. She cites to the landmark decision U.S. v. Philip Morris that found the industry liable for violating federal racketeering law and states that it is “beyond dispute that the tobacco companies have engaged in a decades-long campaign to deceive consumers . . .” The government must only show that the targeted speech creates a possibility of deception where misleading commercial speech is involved and the Zauderer standard of review, which FDA would be able to meet, should apply.

The result is that the regulations for implementing the graphic warnings are rendered void and the matter is referred back to the FDA. The agency can now appeal this decision and seek an en banc review by the full D.C. Circuit Court of Appeals, appeal to the U.S. Supreme Court, or accept the ruling. Were it to appeal the ruling, it could result in a reversal which would allow the warnings to go forward or it could result in a Supreme Court decision that could limit the ability of government to require disclosures or warnings that go well beyond cigarettes and expand the boundaries of commercial free speech.

Conceivably, FDA could begin the rulemaking process again and try to state the government interest in a manner that would not require the precise type of scientific evidence of effectiveness that the Court deemed necessary in today’s ruling. Some of the graphic images could be replaced with others that might be more in keeping with the Court’s requirement for communication information rather than “ideology,” which was referred to in its opinion. Those rules would inevitably result in new litigation by the plaintiffs in this action but could yield a better result. However, today’s decision, which goes against the best practices internationally in public health approaches to tobacco and creates an extremely onerous standard of review for warnings might be just bad enough to justify the risk of an appeal.

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The Public Health Advocacy Institute is asking the FDA to investigate and take enforcement action against The Coca-Cola Company’s unlawful use of heart health claims on cans of Diet Coke. In February of 2010, 2011 and 2012, The Coca-Cola Company has released Diet Coke cans labeled with a large red heart symbol, the National Heart Lung and Blood Institute’s “The Heart Truth” Red Dress logo, and references to women’s heart health. Taken together, the large red heart symbol, the Red Dress logo and references to heart health imply a relationship between consuming a specific food, Diet Coke, and reduced risk for heart disease. The cans pictured below represent the cans in circulation in 2012 (left), 2011 (center) and 2010 (right).

The FDA defines health claims to include “any claim made on the label or in labeling of a food…that expressly or by implication, including ‘third party’ references, written statements (e.g., a brand name including a term such as ‘heart’), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition.” 21 CFR § 101.14 (a)(1). In its food labeling guidance the FDA states, “ health claims characterize a relationship between a substance (specific food component or a specific food) and a disease (e.g., lung cancer or heart disease) or health-related condition (e.g., high blood pressure), and are supported by scientific evidence (see 21 CFR 101.1472).” FDA, Guidance for Industry: A Food Labeling Guide (April 2008), http://www.fda.gov. The use of the heart symbol, the phrase “The Heart Truth” and the reference to a national health organization implies that Diet Coke consumption is beneficial to heart health. This claim is not supported by scientific evidence and is not otherwise allowed under FDA regulations.

This type of misbranding is especially damaging to the public because it unequivocally links the product to a desired health outcome through multiple uses of the word “heart” and the use of a heart symbol—expressly the type of symbols, third party references and words the FDA references in its regulations and guidance on health claims for the food industry. The FDA should act immediately to investigate The Coca-Cola Company’s unlawful use of this health claim, issue the appropriate warning letter and take enforcement action as necessary.

A Suffolk Country jury, after finding Lorillard liable on December 14, 2010 for the wrongful death of a woman who was given free Newport cigarettes by the company as a child growing up in a Boston public housing project, today issued a punitive damages verdict of $81 million against the maker of Newports.

The jury heard testimony from an economist and an accountant who discussed the assets of Lorillard and its ability to pay. The plaintiff called forensic economist Robert Johnson who testified that Lorrilard’s net sales this year came out to about $81 million for a 5 day work week. He also noted that Lorillard was on track to make a profit of over a billion dollars this year.

The defense called local certified public accountant, Robert H. Temkin, who suggested that Lorillard’s ability to pay was less than what Johnson suggested.

The defense’s closing argument, delivered by Shook, Hardy & Bacon’s Walter Cofer, told the jury that, although he shares a name with his grandfather, they are not the same man. Likewise, he reasoned, the Lorillard of today is not the same company that parked a truck next to a playground and gave free cigarettes to children.

The purpose of punitive damages is to punish bad conduct and deter future bad conduct. Cofer argued that that because the tobacco industry is now regulated the the U.S. Food and Drug Administration, the regulatory agency will ensure that no future bad conduct takes place. As for the punishment, Cofer analogized that it was sometimes necessary to “whack a mule on the rump” to get it moving in the right direction. But, he said, once that mule was heading the right way, there was no need to keep whacking it. Lorillard now admits that its products are addictive and deadly, so “whacking it again and again is not necessary.”

Michael Weisman of Davis, Malm & D’Agostine in Boston told the jury that just because Lorillard is now subject to new federal regulatory authority, it does not get them off the hook for what they did and what they do not now do, like make a serious commitment to keep kids from smoking today.

The jury was instructed by judge Elizabeth M. Fahey to consider the character, duration, and nature of Lorillard’s conduct; the actual harm to the victim in this case; the the magnitude of the harm to potential victims in the future. The jury retired to lunch and, about 90 minutes later, returned the verdict in the amount of $81 million, bringing the total liability in the trial to $152 million.

Judge Fahey has yet to rule on the question of Lorillard’s liability under Massachusetts consumer protection law, which could increase the defendant’s total liability. Lorillard is expected to seek a reduction in the amount in its post-trial motions. It will then likely appeal to the Massachusetts Appeals Couort, then the Massachusetts Supreme Judicial Court, and, if necessary, to the U.S. Supreme Court.

Mark Gottlieb, Director of the Public Health Advocacy Institute at Northeastern University School of Law, who was present for today’s hearing, noted that: “the total verdict of $152 million is currently the largest verdict in an individual smoking and health case. Larger verdicts in California and Florida were later reduced. The jury’s message to Lorillard was clear: ‘What was done to Ms. Evans was totally unacceptable.’ More cases involving addicting children with free samples will almost certainly be filed as a result of this case.”

Senior Attorney Edward L. Sweda, Jr., noted, “Today’s award of $81 million in punitive damages clearly reflects this American jury’s outrage at the predatory conduct of Lorillard Tobacco Company – conduct that was a legal cause of Marie Evans’ death from lung cancer at age 54.”

What kinds of High Fructose Corn Syrup Are Generally Recognized as Safe for Use in the Food Supply?

Substances “reasonably expected to become a component of food” are food additives subject to premarket approval by the Food and Drug Administration (FDA), unless they are generally recognized as safe (GRAS).[1] In 1983, the federal government listed high fructose corn syrup (HFCS) as GRAS, and the FDA affirmed that decision in 1996. Federal law defines HFCS as “a sweet, nutritive saccharide mixture containing either approximately 42 or 55 percent fructose.”[2] Accordingly, HFCS typically is commercially available as HFCS-42 (42% fructose) or HFCS-55 (55% fructose). The basic rationale behind granting HFCS GRAS status was that it contains essentially the same ratio of fructose to glucose as table sugar (table sugar is 50% fructose and 50% glucose). Consistent with this logic, in its 1996 review of the GRAS status of HFCS, the FDA expressly rejected a proposal to expand the definition of HFCS to include “HFCS-90” (90% fructose), “primarily because HFCS-90 does not contain approximately equimolar amounts of glucose and fructose.”[3] HFCS-90 does not have GRAS status, and FDA food labeling laws require that HFCS be listed as an ingredient separate from other sweeteners.[4]

Do Fructose Levels in Popular Soft Drinks Containing HFCS Conform to the GRAS Standard?

In a recent study published in the journal Obesity, Ventura et al. purchased a mix of twenty three bottled and fountain dispensed sweetened-beverages and had them tested by an independent laboratory to determine, among other things, the fructose to glucose ratio of popular full-calorie soft-drinks. Laboratory testing revealed that bottled full-calorie Pepsi, Coca-Cola and Sprite had fructose estimates of 64-65%, well in excess of the upper-level of 55% fructose generally recognized as safe by the Food and Drug Administration.[5] The study extrapolated from this finding that the elevated fructose levels equated to “18% higher fructose consumption than would be estimated assuming the value of 55% HFCS.”[6] This preliminary finding has potentially important public health implications,[7] and is important because a key part of the GRAS process is to estimate the population-wide consumption of the substance being evaluated. [8]

What Legal Issues Would Be Implicated by Elevated Fructose Levels in Popular Soft-Drinks?

Ventura et al.’s study reflects a very small sample size. Elevated fructose levels in popular soft drinks, if confirmed by additional testing implicate a number of legal issues for regulators and consumers.

Federal Prohibition of False and Misleading Food Labeling

The Federal Food Drug and Cosmetic Act prohibits false and misleading food labeling, and “food is misbranded if its labeling is false or misleading in any particular.”[9] Federal law specifically defines HFCS “as mixture containing either approximately 42 or 55 percent fructose.”[10] These are the only HFCS formulations that are GRAS and permitted for widespread use in the food supply without prior approval. Absent another source of fructose disclosed in the ingredients list, it would be false and misleading to list “HFCS” on the ingredient list when the product in fact contains a higher ratio of fructose to glucose than required by the legal definition of the ingredient. As such, under federal law the product would be misbranded.

Federal Prohibition of Adulterated Foods

The FDA summarized its adulterated food policy in a guidance document to the food industry as follows:

“Any substance added to a beverage or other conventional food that is an unapproved food additive (e.g., because it is not GRAS for its intended use) causes the food to be adulterated under section 402(a)(2)(C) of the FFDCA (21 U.S.C. 342(a)(2)(C)). Adulterated foods cannot be legally imported or marketed in the United States.”[11]

HFCS that does not conform to the GRAS ratio of no more than 55% fructose is not GRAS for widespread use in the food supply. Under a plain reading of the FDA’s adulterated food policy, use of such a sweetener in a beverage would constitute the use of an unapproved food additive rendering the product adulterated.

False and Misleading Advertising

Federal and state laws generally prohibit false and misleading advertising. In 2008, the Corn Refiners Association launched a national multimedia advertising and public relations campaign called “Changing the Conversation about High Fructose Corn Syrup.”[12] The central message of the campaign is that HFCS is essentially the same as table sugar with respect to the ratio of fructose to glucose and is therefore safe:

“High fructose corn syrup is nearly identical in composition to table sugar — both contain approximately 50% glucose and 50% fructose. Sugar and high fructose corn syrup have the same number of calories as most carbohydrates; both have four calories per gram. Because they are nearly compositionally equivalent, the human body cannot tell the difference between high fructose corn syrup and sugar.”[13]

If additional testing of foods and beverages sweetened with HFCS reveals widespread actual fructose levels in excess of 55%, then the representation that HFCS is “compositionally equivalent” to table sugar could amount to false and misleading advertising requiring action by the Federal Trade Commission and State Attorneys General.

On May 20, 2010, the Commonwealth of Virginia executed Darick Demorris Walker, who had been convicted of murdering Stanley Beale in 1996 and Clarence Elwood Threat in 1997. Also on May 20, 2010, the Altria Group, Inc. Annual Shareholders Meeting took place in Richmond, Virginia.

During the meeting’s question and answer session, shareholder Anne Morrow Donley asked chairman and chief executive officer, Michael E. Szymanczyk the following question: “Earlier this year, the U.S. Supreme Court made a quite controversial decision, noting that essentially corporations are like people. Therefore, fair is fair. There’s a death penalty when murder is committed, so it seems only fair that there should be a corporate death penalty for this company because it admits that it is making a product that kills people. A corporate death penalty could require Altria to apologize for its weapons of mass destruction and could require Altria to cease and desist from the destruction of life. So my question is, since the company itself has admitted in legal proceedings that it makes products which kill people, and courts in various states have upheld challenges from the company saying that Altria is legally responsible for the deaths of customers, therefore, why should not Philip Morris, or Altria itself, not be subject to the death penalty?”

His response was to fall back on the tired refrain that cigarettes are a “legal product” and that people, aware of smoking’s risks, still choose to do so.

FLORIDA LAWSUITS

Having noted that Philip Morris had lost jury verdicts in seven “Engle Progeny” cases during a 15-month span, Tobacco Products Liability Project Senior Attorney Edward L. Sweda, Jr. asked Mr. Szymanczyk when his company will change its policy of refusing to settle the “Engle Progeny” cases, which number approximately 9500. His response was to declare that Altria is “bullish” about the long-term prospects of tobacco litigation in the United States. He said this even though in recent years, when state legislatures considered bills to put an artificial cap on total awards against tobacco companies in product liability cases, company lobbyists have supported such bills by portraying the company as risking bankruptcy if the caps were not imposed. Mr. Szymanczyk’s “bullish” comment became the headline in the Richmond Times-Dispatch’s account of the meeting.

ALTRIA’S ATTEMPT TO REMOVE CERTAIN PANELISTS FROM A SCIENTIFIC PANEL DESIGNED TO ADVISE THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)

During his business presentation just prior to the question and answer session, Mr. Szymanczyk cited the company’s “Mission,” which includes a pledge that it will “actively participate in resolving societal concerns that are relevant to our business.” Shareholder Rev. Michael Crosby of the Interfaith Center for Corporate Responsibility, noted that, according to a report in late April in the Wall Street Journal in March 2010 Altria had attempted to remove four members of an FDA advisory panel because of alleged conflicts of interest. The FDA rebuffed Altria’s attempt to remove those panelists. Fr. Crosby said that such a power play by Altria contradicted that pledge. Mr. Szymanczyk’s response was that the company is “participating in” the FDA’s regulatory process and that “part of participating involves representing shareholder interests.’

SHAREHOLDER RESOLUTIONS

There were two shareholder resolutions considered at the 2010 Shareholders Meeting. The first, which called on the company to “commission an independent study and issue a resulting report on the affect of our company’s marketing on the purchasing practices of poor people. Shareholders ask that this report offer ways to alleviate the harm done to innocent children, such as food insecurity, by such adults who smoke. Shareholders ask that this report include recommendations as to whether our Company should continue marketing its products in census tracts with over 50% poverty.” Supporters of this resolution noted that families with at least one smoker spend 2% to 20% of their income on tobacco. In many instances, such spending deprives children of necessities such as food.

Management opposed this resolution, claiming that Philip Morris USA’s “responsible marketing practices, cessation support and the regulatory authority of the United States Food and Drug Administration (‘FDA’) are sufficient to address the concerns raised by this proposal.”

This resolution received 4.3% of the total number of shares and, thus, is not eligible to be refilled for the 2011 Shareholders Meeting.

The second resolution called on the company to create human rights protocols for itself and its suppliers. Noting that Philip Morris USA contracts with suppliers who employ migrant farm workers, the proponents cited the serious problems of Green Tobacco Sickness (GTS). GTS occurs when the skin absorbs nicotine from touching tobacco plant; the illness threatens more than 33 million tobacco farm workers globally. The shareholders supporting this resolution “request the Altria Board of Directors to commit itself to create procedures to implement the internationally agreed-upon core human rights conventions in the countries in which it operates and to find ways to ensure that its suppliers are enforcing these as well.”

Management opposed the resolution, claiming that there are already sufficient practices and programs in place in the United States that “address farm safety and working conditions.” This resolution received 20.5% support and will therefore be eligible for submission next year.

In response to a request for comments, PHAI urges the FDA to prioritize smoked tobacco nicotine reduction as a potentially highly effective tool to mitigate the public health cost of smoking. Please see our complete Comments (pdf).